ALK21-025: Vivitrol's Cost and Treatment Outcomes Registry (VICTORY)

November 15, 2018 updated by: Alkermes, Inc.

VIvitrol's Cost and Treatment Outcomes RegistrY

The objective of the VIVITROL Registry is to gather real world data on opioid dependence and to provide understanding of the health economics of opioid dependence.

Study Overview

Status

Completed

Conditions

Detailed Description

The VIVITROL Registry is an observational, open-label, single-arm, multi-center registry of patients who have initiated treatment with VIVITROL for prevention of relapse to opioid dependence, following opioid detoxification.

The objectives of the VIVITROL Registry are:

  • To describe characteristics of patients receiving VIVITROL for opioid dependence in real-world clinical practice.
  • To assess clinical, health economic, and health-related quality of life (HRQOL) outcomes in a broad population of patients receiving VIVITROL in real-world clinical practice.
  • To provide additional data to inform future research on VIVITROL.

Patients 18 years of age or older who have been determined by their participating prescriber to be an appropriate candidate for VIVITROL treatment may be offered enrollment into the registry. The decision to treat a patient with VIVITROL will be made by the patient's participating prescriber independent of the registry. VIVITROL will not be provided to patients enrolled in the registry in exchange for their participation; patients will receive commercially available VIVITROL via a standard prescription that will be filled through standard commercial channels.

Patients will be observed while receiving VIVITROL and for six months after they discontinue VIVITROL use. The registry is non-interventional; it will neither direct the treatment plan for enrolled patients nor define the frequency of follow-up visits of each patient. A patient's participation in the registry will not influence or direct patient treatment procedures or follow-up care. It is expected that patients will be seen at least once per month during active VIVITROL treatment to receive their monthly injection.

During the standard monthly injection visits, patients will be asked to provide detailed health economics information using a variety of questionnaires, including the EQ-5D and SF-12v2.

Study Type

Observational

Enrollment (Actual)

403

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Assisted Recovery Centers of America
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • Arkansas Psychiatric Clinc
    • California
      • Ben Lomond, California, United States, 95005
        • Amy Solomon, MD
      • Clovis, California, United States, 93611
        • Touchstone Medical Group
      • Palm Springs, California, United States, 92262
        • Kenneth C. Russ, MD
      • Tarzana, California, United States, 91356
        • Tarzana Treatment Centers
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • The NeuroBehavioral Institute of Colorado, PC
    • Connecticut
      • Groton, Connecticut, United States, 06340
        • Psychotherapy Services, Etc.
    • Florida
      • Tamarac, Florida, United States, 33321
        • Jacqueline Boutrouille, MD
      • Winter Park, Florida, United States, 32792
        • Alliance Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Medicine and Research
      • Decatur, Georgia, United States, 30030
        • PACT Atlanta
    • Massachusetts
      • Centerville, Massachusetts, United States, 02632
        • Gosnold-Thorne Counseling Center
      • Milford, Massachusetts, United States, 01757
        • Dr. Li's Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63109
        • Assisted Recovery Centers of America
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurologic Institute
      • Great Neck, New York, United States, 11021
        • Dr. Michael Sanders
      • Hopewell Junction, New York, United States, 12533
        • Fakhouri Medical
      • New York, New York, United States, 10016
        • Parallax Center
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Healing Comfort Clinic
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Jasper Health
      • Plymouth Meeting, Pennsylvania, United States, 19462
        • Institute of Addiction Medicine
    • Tennessee
      • Johnson City, Tennessee, United States, 37604
        • Innovation Laboratory/PEARL
    • Texas
      • Dallas, Texas, United States, 75225
        • Urschel Recovery Science Institute
      • Dallas, Texas, United States, 75230
        • Holiner Psychiatric Group
      • Dallas, Texas, United States, 75231
        • Lenae White, MD, PA
    • Utah
      • Bountiful, Utah, United States, 84010
        • Utah Addiction Medicine & Counseling
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Adolescent and Family Health Center, PC
      • Newport News, Virginia, United States, 23606
        • Chessen and Associates
    • Washington
      • Bellevue, Washington, United States, 98005
        • Creekside Center for Integrative Medicine
      • Bothell, Washington, United States, 98011
        • Child and Adolescent Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The VIVITROL Registry will enroll patients who have been prescribed VIVITROL for the prevention of relapse to opioid dependence, following opioid detoxification.

Description

Inclusion Criteria:

  • Patient is aged 18 years or older
  • Patient is diagnosed with a current opioid dependence for which treatment with VIVITROL is being initiated
  • Patient has provided written informed consent
  • Patient is willing and able to provide the information to be collected via the registry's interviews and questionnaires
  • Patient expects to be available for ongoing registry participation

Exclusion Criteria:

  • Prior use of VIVITROL

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alkermes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 23, 2011

First Posted (Estimate)

August 24, 2011

Study Record Updates

Last Update Posted (Actual)

November 16, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALK21-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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